02231248

GUDID H679022312480

5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/48MM

Synthes GmbH

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device IDH679022312480
NIH Device Record Keya1a417b6-bad5-4f81-a352-3d63e3d1984d
Commercial Distribution StatusIn Commercial Distribution
Version Model Number02.231.248
Catalog Number02231248
Company DUNS486711679
Company NameSynthes GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982062161 [Primary]
HIBCCH679022312480 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H679022312480]

Moist Heat or Steam Sterilization


[H679022312480]

Moist Heat or Steam Sterilization


[H679022312480]

Moist Heat or Steam Sterilization


[H679022312480]

Moist Heat or Steam Sterilization


[H679022312480]

Moist Heat or Steam Sterilization


[H679022312480]

Moist Heat or Steam Sterilization


[H679022312480]

Moist Heat or Steam Sterilization


[H679022312480]

Moist Heat or Steam Sterilization


[H679022312480]

Moist Heat or Steam Sterilization


[H679022312480]

Moist Heat or Steam Sterilization


[H679022312480]

Moist Heat or Steam Sterilization


[H679022312480]

Moist Heat or Steam Sterilization


[H679022312480]

Moist Heat or Steam Sterilization


[H679022312480]

Moist Heat or Steam Sterilization


[H679022312480]

Moist Heat or Steam Sterilization


[H679022312480]

Moist Heat or Steam Sterilization


[H679022312480]

Moist Heat or Steam Sterilization


[H679022312480]

Moist Heat or Steam Sterilization


[H679022312480]

Moist Heat or Steam Sterilization


[H679022312480]

Moist Heat or Steam Sterilization


[H679022312480]

Moist Heat or Steam Sterilization


[H679022312480]

Moist Heat or Steam Sterilization


[H679022312480]

Moist Heat or Steam Sterilization


[H679022312480]

Moist Heat or Steam Sterilization


[H679022312480]

Moist Heat or Steam Sterilization


[H679022312480]

Moist Heat or Steam Sterilization


[H679022312480]

Moist Heat or Steam Sterilization


[H679022312480]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-28
Device Publish Date2015-09-14

Devices Manufactured by Synthes GmbH

10886982313690 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 3H/93MM
10886982313706 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 3H/93MM/STERILE
10886982313713 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 5H/119MM
10886982313720 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 5H/119MM/STERILE
10886982313737 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 3H/93MM
10886982313744 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 3H/93MM/STERILE
10886982313751 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 5H/119MM
10886982313768 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 5H/119MM/STERILE

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.